Results Summary
What was the research about?
Patients living with advanced heart failure have three treatment options: a heart transplant, medicine, or a left ventricular assist device, or LVAD. An LVAD is a device that doctors surgically place in the heart to help pump blood. Transplants can save lives but not all people qualify for them and hearts are not always available. Medicine can improve symptoms but may not stop heart failure. LVAD treatment can help patients live longer and improve symptoms, but it has risks such as stroke and infection. Patients facing this decision may not have all the information they need to choose a treatment.
The research team created a decision aid to help patients learn if LVAD treatment is right for them. Decision aids help people decide on treatment based on what is most important to them. The team wanted to see if the decision aid helped patients learn about LVAD treatment.
What were the results?
One week after deciding on a treatment, patients who used the decision aid knew more about LVAD treatment than patients who didn’t use the decision aid. But after one month, there was no difference in how much both groups knew.
Patients who used the decision aid said they felt more informed about their treatment decision than patients who didn’t use the decision aid. Of patients who chose LVAD treatment, those who used the decision aid were more satisfied with their lives than patients who didn’t use the decision aid.
There were no differences between these groups in the number of patients who chose to get LVAD treatment or said that life with an LVAD was closer to what they expected.
Who was in the study?
The study included 98 patients ages 30–80 with advanced heart failure. Of these patients, 77 percent were male and 23 percent were female. The patients received care from clinics in Houston, Cleveland, Oklahoma City, and New Orleans. All of the clinics specialized in LVAD treatment.
What did the research team do?
The research team assigned patients by chance to one of two groups. In both groups, patients learned about LVAD treatment from standard education materials from the clinics. Patients in one group also received a paper copy of the decision aid and viewed the decision aid on a website. The research team developed the decision aid with input from people with advanced heart failure, caregivers of people with advanced heart failure, and doctors.
The team asked patients to fill out three surveys. Patients filled out one survey before receiving the standard education materials or the decision aid. This first survey asked patients how much they knew about LVAD treatment and how satisfied they were with life before they made a treatment decision.
The research team then asked patients to fill out the second survey. Patients who chose not to have LVAD treatment filled out this survey one week after the first meeting. Patients who chose to have LVAD treatment filled out this survey one day before surgery, or about a week later. This survey asked how much patients knew about LVAD treatment and how informed they felt making a decision about LVAD treatment.
One month after the first survey, patients filled out a third survey. This survey asked patients how much they knew about LVAD treatment and how satisfied they were with life. For patients who received LVAD treatment, the survey asked if life with an LVAD was what they expected.
What were the limits of the study?
Patients completed surveys within one month after viewing the website or standard educational materials. The research team doesn’t know if patients who viewed the website and chose LVAD treatment will continue to feel more satisfied with their lives.
Future research could test if the effects of the decision aid last longer than one month.
How can people use the results?
Clinics that serve patients with advanced heart failure may consider using this decision aid to help patients choose a treatment.
Professional Abstract
Objective
To determine whether a decision aid for patients with advanced heart failure increases patient knowledge about the benefits and risks of treatment with a left ventricular assist device (LVAD) compared with standard clinic LVAD education
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 98 adults ages 30–80 who were candidates for LVAD treatment |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient knowledge about LVAD treatment Secondary: patient satisfaction with life, how informed patients were about decision to get LVAD treatment, patient expectation for LVAD outcomes, number of LVAD treatments |
| Timeframe | 1-month follow-up for primary outcome |
This randomized controlled trial tested the effectiveness of a decision aid in helping patients with advanced heart failure increase their knowledge about LVAD treatment compared with standard clinic LVAD education. Patient decision aids help people make informed choices among healthcare options that are consistent with their values. The decision aid in this study described the benefits and risks of three treatment options for advanced heart failure: LVADs as a permanent treatment, LVADs as a temporary treatment while waiting for a heart transplant, or medication.
The research team created the decision aid using standards from the Ottawa Decision Support Framework and international decision aid guidelines. To develop the decision aid, the team interviewed candidates for LVAD treatment, patients who had LVADs, caregivers of patients with LVADs, patients that declined LVAD treatment, and clinicians, including cardiac surgeons and a cardiologist.
The study included 98 patients ages 30–80 with advanced heart failure who were candidates for LVADs; 77% of patients were male and 23% were female. Researchers recruited patients from clinics specializing in LVAD treatment in Houston, Cleveland, Oklahoma City, and New Orleans.
The research team randomly assigned patients to an intervention group, in which patients used the decision aid in addition to standard clinic education about LVAD treatment, and a control group, in which patients received only standard clinic education about LVAD treatment. Patients in the intervention group received a paper copy of the decision aid. They also looked at a website with an online version of the decision aid and informational videos.
The research team surveyed patients three times:
- At the initial meeting prior to receiving the decision aid or standard education about LVAD treatment
- One week later, or, if the patient chose LVAD treatment, the day before LVAD surgery
- One month later
All surveys asked patients about their knowledge of LVAD treatment. The initial survey also asked how satisfied patients were with life. The second survey asked how informed patients felt about making a decision for or against LVAD treatment. The final survey asked again about patients’ satisfaction with life. For patients who received an LVAD, the survey also asked if life with an LVAD was what they had expected.
Results
- Patients in the intervention group had significantly greater LVAD treatment knowledge than patients in the control group at one week (p<0.01). There was no difference between groups at one month.
- Compared with patients in the control group, patients in the intervention group felt more informed (p<0.04) about making a decision for or against LVAD treatment. Among patients who opted for the LVAD treatment, patients in the intervention group had greater satisfaction with life (p<0.006) compared with those in the control group.
- There was no difference between groups in the number of patients who opted for or against LVAD treatment or the number of patients who reported that life with the LVAD was close to what they had expected.
Limitations
Because patients completed surveys within one month of the intervention, it is unclear whether results like greater satisfaction among patients in the intervention group will persist over a longer timeframe.
Conclusions and Relevance
A decision aid can help patients learn about the benefits and risks of LVAD treatment during the decision-making period.
Future Research Needs
Future research could determine whether the decision aid’s effects persist over longer periods of time.
Final Research Report
View this project's final research report.
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also confirms that the research has followed PCORI’s Methodology Standards. During peer review, experts who were not members of the research team read a draft report of the research. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. Reviewers do not have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve how the research team analyzed its results or reported its conclusions. Learn more about PCORI’s peer-review process here.
In response to peer review, the PI made changes including
- Elaborating on the representativeness of the stakeholders who participated in the early development of the study. In responding to reviewer concerns that these stakeholders represented successful left ventricular assistive device (LVAD) treatment, the researchers added descriptions of the adverse events experienced by two of the stakeholders and pointed out that in their first aim, they completed in-depth interviews with 10 patients who had declined LVAD treatment. These perspectives were included in the risks section of the decision aid.
- Explaining that the report’s description of a lack of bias in the decision aid was based on the observation that patients who received the decision aid did not make systematically different decisions than those who did not receive it. The reviewers were not clear that this observation reflected a lack of bias.
- Confirming that although they were not able to achieve their originally planned sample size of 144 patients, the study was sufficiently powered with the actual sample size of 105 patients.
- Noting that the researchers did not consider whether materials given to patients in routine clinical care overlapped or contradicted the material in the decision aid. Such materials would be clinic-specific and might therefore contribute to unmeasured differences among clinics.
- Adding a description of plans for evaluating and updating the decision aid, since technology and clinical care for LVAD patients is rapidly advancing.